Diabetes Care and Hormone Clinic, Ahmedabad, Gujarat, India.
FICP Department of Endocrinology & Metabolism, Institute of Post Graduate Medical Education & Research, Kolkata, West Bengal, India.
Diabetes Metab Syndr. 2021 Sep-Oct;15(5):102264. doi: 10.1016/j.dsx.2021.102264. Epub 2021 Sep 1.
To evaluate the safety with respect to QTc prolongation and effectiveness of Teneligliptin in Indian Type 2 Diabetes Mellitus (T2DM) patients.
Retrospective data of T2DM patients on teneligliptin 20 mg or 40 mg once daily as a monotherapy or add-on therapy and having ECG records (before and after teneligliptin initiation) was collected. Safety was evaluated by change in QTc interval and effectiveness was evaluated by changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and haemoglobin A1C (HbA1c) from baseline to 12-weeks.
There was no significant change in mean QTc interval from baseline [418.68 milli seconds (ms) to 419 ms; mean change +0.33 ms; P = 0.1023] to follow up visit (mean duration 91 days). There was a significant reduction from baseline to 12 weeks in FPG [173.1 mg/dl (9.61 mmol/L) to 128.4 mg/dl (7.12 mmol/L), mean change - 44.64 mg/dl (2.47 mmol/L), P ≤ 0.001], PPG [242.5 mg/dl (13.46 mmol/L) to 176.5 mg/dl (9.79 mmol/L), mean change - 65.93 mg/dl (3.66 mmol/L), P ≤ 0.001], and HbA1c [8.2% (66 mmol/mol) to 7.2% (55 mmol/mol), mean change - 1.00% (10.9 mmol/mol), P ≤ 0.001].
Teneligliptin did not cause QTc interval prolongation and was significantly effective in improving glycemic control.
评估替格列汀在印度 2 型糖尿病（T2DM）患者中的安全性和疗效，主要涉及 QTc 间期延长方面。
收集了接受替格列汀 20mg 或 40mg 每日一次单药或联合治疗的 T2DM 患者的回顾性数据，这些患者有心电图记录（开始替格列汀治疗前后）。安全性通过 QTc 间期的变化来评估，有效性通过空腹血糖（FPG）、餐后血糖（PPG）和糖化血红蛋白（HbA1c）从基线到 12 周的变化来评估。
平均 QTc 间期从基线[418.68 毫秒（ms）到 419ms；平均变化+0.33ms；P=0.1023]到随访时无显著变化（平均随访时间 91 天）。与基线相比，FPG[173.1mg/dl（9.61mmol/L）至 128.4mg/dl（7.12mmol/L），平均变化-44.64mg/dl（2.47mmol/L），P≤0.001]、PPG[242.5mg/dl（13.46mmol/L）至 176.5mg/dl（9.79mmol/L），平均变化-65.93mg/dl（3.66mmol/L），P≤0.001]和 HbA1c[8.2%（66mmol/mol）至 7.2%（55mmol/mol），平均变化-1.00%（10.9mmol/mol），P≤0.001]均显著降低。
替格列汀不会引起 QTc 间期延长，并显著改善血糖控制。
